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Monoclonal Antibodies

ABBV-383 for Multiple Myeloma

Phase 1
Recruiting
Research Sponsored by TeneoOne Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) 2016 criteria.
Must be naïve to treatment with ABBV-383.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial will investigate the safety, effectiveness, and tolerability of ABBV-383 in adult participants with relapsed/refractory MM. Researchers want to measure adverse events and changes in symptoms of the disease.

Who is the study for?
Adults with Multiple Myeloma that has returned or hasn't improved after treatment can join. They must have had at least 2-3 prior treatments, including specific drugs like proteasome inhibitors and anti-CD38 antibodies. For one part of the study, they shouldn't have had BCMA-targeted therapy before.Check my eligibility
What is being tested?
The trial is testing ABBV-383, a new drug for relapsed/refractory Multiple Myeloma. It's given by IV in two parts: first finding the right starting dose then expanding to more patients; another group gets a fixed dose. The study lasts about 3 years with regular hospital visits.See study design
What are the potential side effects?
Specific side effects aren't listed but participants will be closely monitored for any adverse events through medical exams and blood tests during their regular clinic visits throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My multiple myeloma has worsened despite treatment.
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I have never been treated with ABBV-383.
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I've had 3+ treatments including PI, IMiD, and anti-CD38 for my condition.
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I've had 2+ treatments for my condition, including specific targeted therapies.
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I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Arm A (Part 1 and Part 2): Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events
Arm B: Number of Adverse Events (AEs) of Special Interest (CRS and Immune Effector Cell-associated Neurotoxicity Syndrome [ICANS])
Secondary outcome measures
Arm A: Number of Cytokine Release Syndrome (CRS) Events

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm B: ABBV-383 Dose ExpansionExperimental Treatment1 Intervention
Participants previously exposed to BCMA-targeted agents will receive ABBV-383 Dose A in 28 day cycles.
Group II: Arm A (Part 2): ABBV-383 Dose ExpansionExperimental Treatment1 Intervention
BCMA naïve participants will receive the dose of ABBV-383 dose A in 28 day cycles.
Group III: Arm A (Part 1): ABBV-383 Dose EscalationExperimental Treatment1 Intervention
B-cell maturation antigen (BCMA) naïve participants will receive different doses of ABBV-383 in 28 day cycles.

Find a Location

Who is running the clinical trial?

TeneoOne Inc.Lead Sponsor
3 Previous Clinical Trials
490 Total Patients Enrolled
3 Trials studying Multiple Myeloma
490 Patients Enrolled for Multiple Myeloma
TeneoOne IncStudy DirectorTeneoOne Inc.
2 Previous Clinical Trials
490 Total Patients Enrolled
2 Trials studying Multiple Myeloma
490 Patients Enrolled for Multiple Myeloma

Media Library

ABBV-383 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05650632 — Phase 1
Multiple Myeloma Research Study Groups: Arm B: ABBV-383 Dose Expansion, Arm A (Part 1): ABBV-383 Dose Escalation, Arm A (Part 2): ABBV-383 Dose Expansion
Multiple Myeloma Clinical Trial 2023: ABBV-383 Highlights & Side Effects. Trial Name: NCT05650632 — Phase 1
ABBV-383 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05650632 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the ABBV-383 Dose Expansion received regulatory clearance?

"The ABBV-383 Dose Expansion trial has been assigned a safety score of 1. This is because, as it's only in the first clinical testing stage, there are limited data sets available to support its efficacy and safety."

Answered by AI

What is the current extent of facilities conducting this trial?

"For this clinical trial, recruitment is taking place at Mt Sinai /ID# 251166 in New york City, Tulane University /ID# 251204 in New Orleans and Mayo Clinic Arizona /ID# 251405 located in Phoenix along with 6 other medical centres."

Answered by AI

Is there still availability for individuals to join this experiment?

"According to records on clinicaltrials.gov, patient recruitment for this medical trial closed in December of 2022 - as such it is no longer seeking new participants. However, 811 other studies are presently looking for volunteers and patients."

Answered by AI
~80 spots leftby Jul 2026